The Swedish Medicines Agency’s Annual Report for 2025

The Swedish Medical Products Agency has published its Annual Report for 2025. The report describes achievements across the agency’s areas of responsibility, including pharmaceuticals and medical technology, narcotics, cosmetics and tattoo inks, research and development, poison information and drug education, supervision and access, national and international collaboration, regulations and government assignments, sustainability and preparedness, work environment, and skills supply.

Preparedness and Safety

Global concerns regarding increased demands for preparedness and safety characterized the agency’s work in 2025. The agency continued strengthening its own preparedness organization while contributing to a resilient society.

In her foreword, Director General Ann Lindberg states that the agency continues its efforts to reinforce emergency preparedness and support societal resilience.

During 2025, work continued to ensure safe, effective, and equal access to medicines in Sweden. Several government assignments focused on preventing medicine shortages, securing access to medical technology, and strengthening preparedness for crises and heightened alert.

“The issue of preparedness is a major one throughout the EU, and therefore it feels reassuring that Sweden is also cooperating closely with, for example, the European Commission, the European Medicines Agency and sister authorities in Europe to promote the safe and effective development of the use of medicines,” says Ann Lindberg.

In parallel, the agency continued its work within the national medicines strategy, focusing on patient safety, equal care, and cost-effective use of medicines.

Campaign Against Illegal Medicines

As part of its government mandate to combat illegal pharmaceutical trade, the agency launched the information campaign “Fulmediciner.” The campaign aimed to raise awareness of the risks of purchasing illegal medicines and to direct consumers to approved pharmacies. Strengthening public awareness is an important component of Sweden’s resilience in crises.

Selected Figures from 2025

A selection of figures reflecting activities during the year:

• 19,216 reports of suspected adverse reactions
• 767 new medicines approved for sale in Sweden
• 27 published scientific articles
• 1,037 permanent employees
• 117,479 inquiries to the Poison Information Centre
• 7 published monographs
• 1,105 regulatory advisory services
• 169 inspections of pharmaceutical manufacturers and wholesalers
• 2,657 reported leftover pharmaceutical packaging
• 78,059 questions answered by the Swedish Medicines Information Service
• 29 partial or final government assignments reported
• 634 answered questions about cosmetics and tattoo inks
• 3 treatment recommendations

These figures reflect the scope of regulatory oversight, pharmacovigilance reporting, supervision, and access responsibilities carried out in 2025. Maintaining structured pharmacovigilance systems and strong data integrity practices remains essential for organizations operating under European regulatory frameworks, particularly in light of increasing inspection expectations.
https://www.baupharma.com/blogs-posts/data-integrity-in-pharmacovigilance-pv-systems-a-brief-overview/

Organizations operating within regulated environments often strengthen internal pharmacovigilance systems, inspection readiness, and regulatory documentation processes to align with evolving European oversight expectations.
https://www.baupharma.com/services-categories/pharmacovigilance/

Not Just Medicines

The Annual Report outlines achievements across pharmaceuticals and medical technology, narcotics, cosmetics and tattoo inks, research and development, poison information and drug education, supervision and access, national and international collaboration, regulations and government assignments, sustainability and preparedness, work environment, and skills supply.

For more information: The Swedish Medicines Agency’s annual report for 2025